Autoinjector

ABSTRACT

An autoinjector that receives a pre-filled syringe, having a central body and an actuator sleeve provided with one end that comes into contact with the user. The actuator sleeve can be moved between projecting and actuation positions and it is in the projecting position prior to and following the actuation of the autoinjector. An injection mechanism is provided to inject the product when the needle is inserted into the user&#39;s body. The autoinjector also includes a barrel movement device to move the needle into the injection position and retract the needle from the body following injection. The movement device includes a control ring rotatably mounted in the central body, the ring having an inclined internal profile that engages with an internal projection of a control sleeve that can move axially in the central body, such that the sleeve moves axially when the ring is rotated.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a National Stage of International Application No.PCT/FR2013/051136 filed May 24, 2013, claiming priority based on FrenchPatent Application Nos. 1254857 filed May 25, 2012, U.S. Pat. No.1,259,116 filed Sep. 27, 2012 and U.S. Pat. No. 1,352,517 filed Mar. 21,2013, the contents of all of which are incorporated herein by referencein their entirety.

The present invention relates to an autoinjector.

Autoinjectors are well known in the prior art. The main aim of thesedevices is to carry out automatic injection of the contents of a syringeinside the body of a patient. There are various systems for automatingpenetration of the needle into the body of the patient as well asinjection of the fluid product contained in the syringe. Autoinjectorsare relatively complex devices that must respond to a certain number ofrequirements of stresses to be reliable. The robustness of the device,its handling, and its ease of use for the user are also importantelements. In addition, as the majority of these autoinjectors is singleuse, the cost of manufacture and assembly is also a factor to be kept inmind.

There are numerous autoinjectors on the market, all of which howeverhave some disadvantages.

Therefore, to prevent untimely triggering of the autoinjector, forexample during transport or storage, devices must comprise reliablelocking means. Similarly, when a user wants to utilize the autoinjectorand unlocks the device, for example by removing the cap, the device mustnot actuate prematurely but only when the user really wants it, that is,at the moment when he applies it to the part of the body in which hewants to carry out the injection. Now, especially when those peopleusing the autoinjector are elderly or handicapped people, it can happenthat the user drops the device just when he wants to use it. It ispreferable in such a case that the autoinjector does not actuate on itsown. It is therefore important to provide a reliable triggering lock.From another viewpoint, using the autoinjector should not become toodifficult, which would prevent weak people from using it. It istherefore difficult to find a good compromise between the security ofthe locking and the ease of use and actuation of the autoinjector. It isone of the aims of the present invention to respond to this problem.

In addition, according to the volume of the fluid product distributedduring injection and also as a function of its viscosity, the timeneeded to complete this injection can be fairly substantial, and mayespecially exceed several seconds. It is very important that the usernot remove the device from his body before the injection is complete. Itis therefore preferable for the device to comprise means for indicatingreliably to the user that the injection is finished.

It is also important to ensure that the product is injected to thecorrect depth in the body, that is, in the right tissue. So masteringthe start of injecting, to ensure there that will start only when theneedle reaches its definitive pricking position, is therefore also animportant aspect.

Also, to avoid any risk of injury after use of the device, theautoinjector must comprise a needle safety device which prevents theneedle from being conspicuous after use of the device. This safetydevice must obviously also be reliable and not be released too easily.It must also be functional even if the user improperly activates theautoinjector, for example if he removes it too early from his body,prior to completion of the injection.

Another important aspect of autoinjectors, especially when the volume offluid product is relatively large and/or when the fluid product injectedis relatively viscous, is to allow the product to diffuser from theinjection site for a few seconds after said injection. If the userremoves the autoinjector immediately after the end of the injection,part of the product can flow back out of the body of the user, whichdiminishes the efficacy of the treatment. It is therefore preferable toprovide that the user holds the autoinjector against his body for a fewmore seconds after the end of the injection. This aspect is generallyresolved by existing autoinjectors by the notice of use which asks theuser to count in his head for a certain number of seconds beforeremoving the device. This is not reliable and therefore unsatisfactory,as the system then depends on the user himself who in some cases can beperturbed or weakened by what he has just done.

Documents WO2012045833, EP1743666, WO2009095701, WO2012022810,EP2399632, FR2884722, WO9632974, WO2012000832, US2008281271,WO2009040602, WO2009040604, WO2009040607, WO2010108116, WO2011048422,EP2399628, WO2008112472, WO2011101380, WO2011101382, US2005273055,FR2905273, WO2009062508, WO2009037141 and GB2463034, describe devices ofthe prior art.

The aim of the present invention is to provide an autoinjector that doesnot reproduce the abovementioned disadvantages and which responds to thedifferent requirements and considerable restrictions for safe andreliable use of the autoinjector.

Another aim of the present invention aim is to provide an autoinjectorthat is reliable in use, which ensures distribution of all the fluidproduct at the planned site, which allows the user to determine when hemust remove or when he can withdraw the autoinjector from his body afterits use, which is safe and that avoids any risk of injury, and that issimple and not costly to manufacture and assemble.

The aim of the present invention is therefore to provide an autoinjectorcomprising a lower body receiving a tank, said tank containing fluidproduct and comprising a piston and a needle, such as a pre-filledsyringe, said autoinjector comprising a central body fastened to saidlower body and an actuating sleeve provided with a contact end designedto make contact with the body of the user, said actuating sleeve beingmoveable between a projected position and an actuation position, saidactuating sleeve being in a projected position prior to and afteractuation of the autoinjector, injection means being provided to injectsaid fluid product through said needle when said needle is in aninjection position in which it is inserted in the body of the user, saidautoinjector comprising a tank movement device, on the one hand to movethe needle towards said injection position, and on the other hand toretract said needle out of the body of the user after injection of thefluid product, said tank movement device comprising a control ringrotatably mounted in said central body, said control ring comprising afirst internal inclined profile adapted to cooperate with an internalprojection of a control sleeve secured to the tank, said control sleevebeing moveable axially in said central body, such that rotation of thecontrol ring causes said control sleeve to move axially, said controlring being stressed in rotation by a pricking spring, in particular atorsion spring, the rotation of said control ring being blocked by acontrol slide that is moveable axially in said central body, saidactuating sleeve cooperating, when it arrives in its actuation position,with said control slide to move it axially so as to unblock the rotationof said control ring and thus move the tank towards the injectionposition of the needle, the control slide comprising a projection thatblocks the rotation of the control ring until the actuating sleeve is inits actuation position, said projection cooperating with an externalinclined ramp of said control ring during its rotation, which brings theneedle into its injection position, such that said control slide ismoved axially relative to said control ring during said rotation.

Advantageously, said actuating sleeve cooperates, in the actuationposition, with said tank movement device to move said needle towards itsinjection position.

Advantageously, the autoinjector comprises an injection lock to blocksaid injection means, said tank movement device unblocking saidinjection lock and actuating said injection means when the needle is inthe injection position.

Advantageously, said injection means cooperate with said tank movementdevice after injection of the fluid product to retract said needle.

Advantageously, after the needle has arrived in the injection position,the control ring unblocks the injection lock, actuating the injectionmeans, said control slide cooperating with said control ring to blockthe rotation of said control ring once again.

Advantageously, a trigger cooperates with said control slide after theend of injection to move it axially to block the rotation of saidcontrol ring once again, and thus move the tank towards the retractedposition of the needle.

Advantageously, said actuating sleeve cooperates with said control slidesuch that when said actuating sleeve is returned to its second projectedposition after or during actuation, said control slide is moved intoposition for unblocking the rotation of the control ring, so as toactuate retraction of the needle.

These characteristics and advantages and others of the present inventionemerge more clearly from the following detailed description, given inreference to the attached drawings, given by way of non-limitingexamples, and in which:

FIG. 1 is a schematic exploded view in perspective of the components ofan autoinjector, according to a first advantageous embodiment;

FIGS. 2a to 2f are schematic views in transversal section illustratingthe different sequences of use of the autoinjector of FIG. 1;

FIGS. 3a to 3c illustrate more precisely three different stages of anadvantageous actuating sleeve, respectively before, during and afteruse;

FIG. 4 is a detailed view showing the actuating sleeve in the positionof FIG. 3 a;

FIGS. 5 and 6 are schematic views in transversal section according totwo different sectional planes showing the actuating sleeve in theposition of FIG. 4;

FIGS. 7 and 8 are partially cut schematic views in perspectiveillustrating the actuating sleeve in the position of FIGS. 5 and 6;

FIG. 9 is a view similar to that of FIG. 4, at the start of actuation ofthe autoinjector, during the pricking phase;

FIGS. 10 to 11 are views similar to FIGS. 5 and 6, in the position ofFIG. 9;

FIG. 12 is a view similar to that of FIG. 8, in the position of FIGS. 10and 11;

FIG. 13 is a view similar to that of FIGS. 4 and 9 during actuation, inthe injection phase;

FIGS. 14 and 15 are views similar to those of FIGS. 10 and 11illustrating the position of FIG. 13;

FIG. 16 is a view similar to that of FIG. 12, illustrating the positionof FIGS. 14 and 15;

FIG. 17 is a view similar to that of FIG. 13, at the end of actuation,when the user removes the autoinjector from the injection site;

FIG. 18 is a view similar to that of FIG. 17, when the actuating sleeveis locked;

FIG. 19 is an exploded schematic view in perspective illustrating anadvantageous injection lock;

FIG. 20 is a sectional transversal schematic view of the injection lockof FIG. 19, in the blocking position;

FIG. 21 is a view similar to that of FIG. 20, in the unblockingposition;

FIG. 22 is a schematic plan view in horizontal section of the injectionlock of FIG. 19, in the blocking position;

FIG. 23 is a partially cut schematic view in perspective of theinjection lock of FIG. 19, in the blocking position;

FIG. 24 is a transversal sectional schematic view of the injection lockof FIG. 19, in the blocking position;

FIG. 25 is a view similar to that of FIG. 23, in the unblockingposition;

FIG. 26 is a view similar to that of FIG. 24 in the unblocking position;

FIG. 27 is an exploded schematic view in perspective of an advantageousretarding device;

FIG. 28 is a transversal sectional schematic view of the retardingdevice of FIG. 27 before its actuation;

FIG. 29 is a sectional schematic view according to the cutting line X ofFIG. 28;

FIG. 30 is a sectional schematic view according to the cutting line Y ofFIG. 28;

FIG. 31 is a view similar to that of FIG. 28, at the end of actuation ofthe retarding device;

FIG. 32 is an exploded schematic view in perspective of an advantageoussyringe movement mechanism;

FIGS. 33 to 35 are partially cut schematic views in perspective of themovement mechanism of FIG. 32, prior to actuation, according to threedifferent orientations;

FIGS. 36 and 37 are views similar to FIGS. 33 and 35, during actuationof the movement mechanism;

FIGS. 38 to 41 are partially cut partial schematic views in perspectiveof the movement mechanism of FIG. 32, when the needle of the syringe hasreached its injection position in the body of the user;

FIGS. 42 and 43 are schematic views of the movement mechanism of FIG. 32at the start of retraction initiated by the retarder;

FIG. 44 is a schematic view of the movement mechanism of FIG. 32 at thestart of retraction initiated by the actuating sleeve;

FIGS. 45 and 46 are view similar to FIGS. 43 and 44, on completion ofinjection;

FIG. 47 is an exploded schematic view in perspective of the componentsof an autoinjector, according to an advantageous second embodiment;

FIGS. 48a to 48e are schematic views in transversal section illustratingthe different sequences of use of the autoinjector of FIG. 47;

FIGS. 49a and 49b are schematic views in perspective illustrating thelower body and the actuating sleeve of the autoinjector of FIG. 47;

FIGS. 50a, 50b and 50c schematically illustrate the cooperation betweenthe actuating sleeve and the lower body of the autoinjector of FIG. 47,respectively in position prior to actuation, after actuation but priorto injection and after injection;

FIG. 51 is a view similar to that of FIG. 50a , illustrating a variantembodiment;

FIG. 52 is a detailed cut enlarged view in perspective, showing avariant of the actuating sleeve with scored bridges;

FIGS. 53a and 53b illustrate schematic views of the autoinjector priorto injection;

FIGS. 54a and 54b are views similar to FIGS. 53a and 53b , afterinjection;

FIG. 55 is a schematic view in perspective of a sound and/or tactileindication device according to an advantageous variant;

FIG. 56 is a view similar to FIG. 55, partially in section;

FIGS. 57a, 57b and 57c show the autoinjector prior to injection;

FIGS. 58a, 58b and 58c show the autoinjector after injection but priorto actuation of the sound and/or tactile indication device;

FIGS. 59a, 59b and 59c show the autoinjector after injection and afteractuation of the sound and/or tactile indication device;

FIG. 60 is a schematic view in perspective exploded illustrating avariant embodiment of the sound and/or tactile indication device;

FIGS. 61 and 62 are schematic views of the control sleeve of the soundand/or tactile indication device of FIG. 61;

FIGS. 63a and 63b are schematic views of the key of the sound and/ortactile indication device of FIG. 61;

FIGS. 64a, 64b and 64c are schematic views of the autoinjector of FIG.60, respectively before unlocking of the injection lock, after unlockingof the injection lock and on completion of injection, illustrating thesound and/or tactile indication device of FIG. 61;

FIG. 65 shows another variant embodiment of the sound and/or tactileindication device;

FIGS. 66a and 66b are schematic views of the support pellet of the soundand/or tactile indication device of FIG. 65;

FIGS. 67a and 67b are schematic views of the key of the sound and/ortactile indication device of FIG. 65;

FIGS. 68a, 68b and 68c are views similar to FIGS. 64a, 64b and 64c ,illustrating the sound and/or tactile indication device of FIG. 65;

FIGS. 69, 70 and 71 are detailed views of FIGS. 68b and 68 c;

FIG. 72 schematically shows a variant embodiment of the actuatingsleeve;

FIG. 73 shows another view of the variant embodiment of FIG. 72; and

FIGS. 74a, 74b and 74c are views similar to FIGS. 50a, 50b and 50c ,illustrating the variant embodiment of the actuating sleeve of FIGS. 71and 72.

The autoinjector is described hereinbelow in reference to diversevariants of two advantageous embodiments thereof. A first embodiment isshown in FIGS. 1 to 46 and a second embodiment is shown in FIGS. 47 to74 c. It is however to be noted that these autoinjectors, which arecomplex devices, comprise several modules for carrying out severalfunctions. These diverse modules can be used separately andindependently of each other, without necessarily being combined withother modules, and could especially be used in autoinjectors of formdifferent to that shown in the drawings.

In reference to FIG. 1, the different components of the autoinjector,according to a first advantageous embodiment, are shown exploded. Inthis first embodiment, and in the order of the reference numerals, theautoinjector comprises a central body 1, a control ring 2, a prickingspring 3, a control sleeve 4, a piston rod 5, a pellet support 6, threeblockage elements 7, here in the form of balls, an injection spring 8, acontrol slide 9, a lower body 10, an actuating sleeve 11, a spring 12 ofthe actuating sleeve, a tank housing 13, a cap 14, an upper body 15, aplurality of planetaries 16, a plurality of satellites 17, a retardantspring 18, a trigger 19, a locking finger 20, a wire 21, an externalshell 22 and a blocking ring 23. All these elements form part of theembodiment described, but all are not indispensable to the operation ofthe autoinjector, as is described more precisely hereinbelow.

The cap 14 especially locks the autoinjector during transport andstorage. As this cap is assembled on the lower body 10, it prevents anyactuation of the actuating sleeve 11, and therefore any triggering ofthe autoinjector.

A tank A can be inserted into said autoinjector. This tank containsfluid product, and comprises a piston and a needle. The piston isadapted to shift in said tank to inject the fluid product through saidneedle. The present description will be given in reference to a syringeA, which can be any type. More generally, it is understood that the term“syringe” in the present description covers any type of tank linked to aneedle.

Preferably, the syringe A is a pre-filled syringe. It advantageouslycomprises a needle cap B which protects and isolates the needle prior touse of the autoinjector. Advantageously, this needle cap B is removedautomatically at the moment when the cap 14 is withdrawn from the lowerbody 10.

FIGS. 2a to 2f illustrate the sequences of the use of the autoinjectorof FIG. 1.

In FIG. 2a , the autoinjector is in the rest position prior to use, thecap 14 having been removed.

When the user wants to use the autoinjector, he takes the device, forexample at the level of the external shell 22 and presses the actuatingsleeve 11, which in a first projected position projects out of the lowerbody 10, against the part of the body where he wants to carry out theinjection. In FIG. 2b , it is evident that pressure exerted by the useron the actuating sleeve 11 causes the latter to slide towards theinterior of the lower body 10, with the effect of compression of thespring of the actuating sleeve 12.

When the actuating sleeve 11 reaches its actuation position, which isits end position inside the lower body 10, it causes triggering of thepricking lock and therefore movement of the control sleeve 4 in thelower body 10 under the effect of the pricking spring 3, consequentlywith movement of the syringe A in the lower body 10 and thereforeinsertion of the needle of the syringe in the body of the user, as isevident in FIG. 2 c.

When the needle reaches its injection position with complete insertionof the needle, the injection phase is triggered, which is shown in FIGS.2c and 2d . It is noted that the piston rod 5 slides inside the syringeA by pushing the piston thereof under the effect of the injection spring8. The product is therefore distributed.

On completion of the injection, and with optionally a certain delay ortime offset, as is described below, the autoinjector provides retractionof the syringe A. The needle is therefore retracted out of the body ofthe user towards the interior of the autoinjector, as shown in FIG. 2 e.

On completion of retraction, the actuating sleeve 11 is again moved outof the lower body 10 towards a second projected position, under theeffect of the spring 12 of the actuating sleeve, with locking of saidactuating sleeve 11, which ensures absolute safety for the user andavoids any risk injury with the needle after use of the device. It isevident that the first and second projected positions of the actuatingsleeve, which in the example shown are different positions, couldoptionally be identical.

An advantageous actuating sleeve is described in more detail hereinbelowin reference to FIGS. 3a to 18.

Said actuating sleeve 11 comprises a flexible foot 110 that has doubleflexibility. It is on the one hand flexible radially that is, it deformstowards the interior of the actuating sleeve 11. It is then alsoflexible laterally that is, it deforms in the peripheral direction ofthe actuating sleeve 11. An actuating sleeve 11 provided with such aflexible foot is simple to mold, which is favorable from the point ofview of manufacturing costs. The flexible foot 110 advantageouslycomprises a rod part 111 that is flexible and which terminates in a headpart 112. Said flexible foot 110 is adapted to deform on the one handradially and on the other hand laterally relative to said central body 1when said actuating sleeve 11 is moved from its first projected positiontowards its actuation position then from its return actuation positiontowards its second projected position. Preferably, said flexible foot110 is deformed radially when said actuating sleeve 11 is moved from itsfirst projected position, prior to actuation, towards its actuationposition, and said flexible foot is deformed laterally when saidactuating sleeve 11 is moved from its actuation position towards itssecond projected position, at the end of use. This is the variant thatis shown in the figures.

FIGS. 3a, 3b and 3c are three partial schematic views in perspectivethat show the end positions of the actuating sleeve 11, specifically inFIG. 3a the first projected position at rest prior to actuation, in FIG.3b the actuation position in which the actuating sleeve 11 has beeninserted to the maximum inside the lower body 10, and in FIG. 3c thesecond projected position with the actuating sleeve 11 locked relativeto the lower body 10, at the end of use.

It is noted that the central body 1 comprises cutouts forming groovesand shoulders that are detailed hereinbelow. The central body 1 is fixedto the lower body 10 and the actuating sleeve 11 is arranged to slideinside said lower body 10.

The central body 1 comprises a substantially axial first groove 101, andan opening 103, separate from said first groove 101 but arranged in theaxial extension of said first groove 101. Said central body 1 alsocomprises a radial cam 102 arranged between said first groove 101 andsaid opening 103. As evident especially in FIGS. 6 and 7, said radialcam 102 can be formed by inclined radial thickening of the wall of thecentral body 1, said thickening being formed at the axial end of thefirst groove 101. Said radial cam 102 cooperates with said head 112 ofsaid flexible foot 110 to radially deform said flexible foot 110 andallow said head 112 to move from said first groove 10 to said opening103 during movement of the actuating sleeve 11 towards its actuationposition.

Said central body 1 comprises a final reception zone 105 offset axiallyand laterally relative to said opening 103. As evident in the figures,this final reception zone 105 is arranged axially around the level ofsaid first groove 101. The opening 103 is connected to said finalreception zone 105 by a laterally inclined groove 104. An axial shoulder106 is provided between said final reception zone 105 and said inclinedgroove 104. Therefore, when said actuating sleeve 11 returns from itsactuation position towards its second projected position, said head 112of the flexible foot 110 slides in said laterally inclined groove 104,laterally deforming said flexible foot 110. When said actuating sleeve11 reaches its second projected position, after use, said head 112 clipsin under said axial shoulder 106, locking said actuating sleeve 11relative to said central body 1 and relative to the lower body 10. Fromthis locked position, said actuating sleeve can no longer be moved inthe direction of its actuation position, due to the stop formed betweenthe head 112 of the flexible foot 110 and the axial shoulder 106.

FIGS. 4 to 8 represent the start position, that is, at the moment whenthe user will commence using the autoinjector. It is evident in thesefigures that the head 112 is arranged in said groove axial 101 of thecentral body 1. When the actuating sleeve 11 slides towards the interiorof the lower body 10, said head 112 of the flexible foot 110 will slideinside said groove 101 of the central body. When the head 112 reachesthe axial end of the first groove 101, said radial cam 102 willcooperate with said head 112. This radial cam 102 will therefore deformthe flexible foot 110, and especially its rod part 111, radially towardsthe interior in the direction of its longitudinal central axis.

FIGS. 9 to 12 illustrate the position in which the flexible foot 110 isradially deformed. As evident especially in FIG. 11, after this radialdeformation the head 112 of the flexible foot 110 will continue to moveaxially over an additional distance to reach said opening 103. Theactuating sleeve 11 reaches its actuation position, as shown in FIG. 13.

In this actuation position, the flexible foot 110 returns elastically toits radially non-deformed position. The head 112 of the flexible foot110 returns inside said opening 103, as is evident in FIG. 14.

The radial deformation of the flexible foot 110, necessary to move theactuating sleeve from its first projected position towards its actuationposition, generates some resistance. Combined with the compression forceof the spring 12, this resistance obliges the user to exert at leastsome predetermined force to perform movement of the actuating sleeve 11inside the lower body 10. This avoids any risk of accidental or unwantedactuation after the cap 14 is removed. Actuation takes place only if theuser exerts said predetermined force on the actuating sleeve 11. Thisforce threshold also creates some precompression in the hand of theuser, the effect of which is that movement of the actuating sleeve 11towards its actuation position is ensured when this threshold isreached.

When the actuating sleeve 11 reaches its actuation position, that is, inthe position of FIGS. 13 to 16, the spring 12 of the actuating sleevehas been compressed and the pricking lock is triggered by said actuatingsleeve 11, as is described in more detail later, which causes movementof the syringe A inside the lower body 10 and therefore pricking of theneedle in the body of the user. Throughout this pricking phase andduring the injection phase which follows said pricking phase, theactuating sleeve 11 does not move relative to the lower body 10, sincethe user maintains his pressure on the part of the body in which he isinjecting.

At the end of use, when the user is going to remove the autoinjectorfrom his body, the spring 12 of the actuating sleeve 11 will stress saidactuating sleeve 11 to return from its actuation position towards itssecond projected position, as is shown in FIG. 3c . During this axialreturn deformation of the actuating sleeve 11 in the lower body 10, thehead 112 of the flexible foot 110 will cooperate with the inclinedgroove 104 as is evident in FIGS. 17 and 18. This will cause elasticdeformation of the flexible foot 110, and especially of its rod part111, to the extent where the actuating sleeve 11 will slide axially, thehead 112 sliding in said inclined groove 104 laterally deforming saidflexible foot 110 as clearly evident in FIG. 17. This inclined groove104 terminates in a final reception zone 105 provided with an axialshoulder 106. At the end of the return path of the actuating sleeve 11,the head 112 of the flexible foot 110 will penetrate this finalreception zone 105 and the upper edge 114 of the head 112 will cooperatewith the axial shoulder 106, which will block the actuating sleeve 11relative to the lower body 10. The actuating sleeve 11 can no longerslide axially towards the interior of the lower body 10, and the safetydevice is then in the final locked position. Therefore, the needle isfully protected after use and the user can no longer utilize theautoinjector or injure himself with the needle.

Of course, the forms of the grooves, their dimensions and theirinclinations can be modified as a function of the preferred needs andcharacteristics for the needle safety device.

The actuating sleeve described above is particularly effective andreliable, and is robust and easy and therefore inexpensive to mold.

FIGS. 32 to 46 describe more particularly the device for movement of thesyringe in the lower body 10. This device for movement ensures on theone hand the pricking, that is, insertion of the needle in the body ofthe user, and on the other hand retraction of the needle afterinjection.

As seen previously, at the start of actuation, the syringe A is movedaxially in said lower body 10 to perform insertion of the needle in thebody of the user. After injection of the fluid product in the body ofthe user, and optionally after some delay provided by the retardingdevice described above, the syringe A is again moved in the otherdirection inside the lower body 10 to be retracted and automaticallywithdraw the needle from the body of the user. In this way, when theuser removes the autoinjector from his body, the needle no longerprojects but instead is retracted inside said autoinjector.

To perform these reciprocal movements of the syringe A in the lower body10, a control ring 2 is provided which cooperates with the controlsleeve 4, with the control slide 9 and with the actuating sleeve 11. Inaddition, the trigger 19 intervenes to perform retraction of the syringeinside the body, as is explained hereinbelow.

FIGS. 33 to 35 illustrate the start position before the syringe is movedfor pricking. It is noted that the control ring 2 is stressed inrotation by the pricking spring 3, which here is a spring acting intorsion. Such a torsion spring performs painless pricking.

In this initial position of FIGS. 33 to 35, rotation of the control ring2 is prevented by a projection 91 of the control slide 9, as is moreclearly evident in FIG. 35.

When the actuating sleeve 11 arrives in its end position inside thelower body 10, as shown in FIG. 3b , a shoulder 118 of said actuatingsleeve 11 will cooperate with a shoulder 92 of the control slide 9 toaxially move said control slide 9 upwards in FIG. 36. This axialdeformation of the control slide 9 will release the rotation of thecontrol ring 2 that will be able to turn under the effect of its loadedpricking spring 3.

The control ring 2 comprises three inclined profiles 24, 25, 26 similarto ramps, whereof the functions are explained hereinbelow.

The control ring 2 comprises a first inclined internal profile 24, suchas a ramp, which will cooperate with a projection 44 of the controlsleeve 4. Therefore, rotation of the ring 2 will progressively axiallymove said control sleeve 4. This control sleeve 4 cooperates with thesyringe housing 13 that receives the syringe, and movement of thecontrol sleeve moves the syringe A in the lower body 10 to performpricking of the needle.

FIG. 39 illustrates the position in which the needle is fully inserted,with the first inclined profile 24 which cooperates with the projection44 of the control sleeve 4.

During movement of the control sleeve 4 and therefore insertion of theneedle into the body of the user, the projection 91 of the control slideis also in contact with an external inclined profile 25 of the ring 2,such as an external ramp, which will cause added axial deformation ofsaid control slide 9 relative to the actuating sleeve 11. This will movethe control slide 9 in the same direction as the actuating sleeve 11during pricking. Because of this, the projection 92 of the control slide9 comes close to an upper projection 119 of the actuating sleeve 11, andthe projection 95 of the control slide 9 comes close to a projection 191of the trigger 19, as is evident in FIG. 44.

The first internal inclined ramp 24 which cooperates with the projection44 of the control sleeve 4 advantageously comprises a flat section 241,that is, a non-inclined portion, evident in FIG. 41. This flat section241 has a very important function since it ensures that the start of theinjection will occur only after the total end of insertion of the needleinto the body of the user. Whereas for many autoinjectors it isnecessary to commence the injection slightly before the needle reachesits final insertion point, for reasons of manufacturing tolerance theflat section 241 on the ramp 24 avoids this phenomenon. In fact, whilethe ring 2 has already completely moved the control sleeve 4 axially andtherefore has completed total insertion of the needle of the syringe inthe body of the user, it is necessary for the ring 2 to turn further onthe arc of a circle formed by said flat section, for example around 30°,to trigger the injection lock. Therefore, the blocking ring 23 of theinjection lock is moved from its blocking position only after the extrarotation of the ring 2 on the arc of a circle formed by said flatsection 241. During this extra rotation, there is no axial deformationof the control sleeve 4, and therefore of the syringe A, since the flatsection 241 is not inclined. Even with manufacturing tolerances, thisguarantees that insertion is finished before injection commences. Inline with this, during this extra rotation of the control ring 2 asecond internal inclined profile 26, such as a ramp, of the control ring2 will cooperate with a projection 235 of the blocking ring 23 of theinjection lock and move the latter from its blocking position to releasethe injection, when the control ring 2 arrives at the end of its extrarotation. This is also evident in FIG. 41. Advantageously, the controlring 2 comprises three second internal inclined profiles 26 arranged at120° to each other, and the blocking ring 23 comprises three projections235 also arranged at 120° to each other, a respective projection 235cooperating with a respective second internal inclined profile 26.

When the injection is triggered by the blocking ring 23, the rotation ofthe control ring 2 is again blocked by the control slide 9.

With the control slide 9 in the position of FIG. 44, if the user removesthe autoinjector from his body while the injection is underway or afterinjection but before the end of the retarder, the spring 12 of theactuating sleeve 11 will stress said actuating sleeve 11 returning fromthe lower body 10. This movement of the actuating sleeve 11 will drawthe control slide 9 axially downwards in FIG. 44 by cooperation betweenthe upper shoulder 119 and the projection 92 of the slider. Therefore,the control ring 2 will again be released in rotation by the controlslide 9, and the spring 3 will stress this control ring more inrotation, which will cause retraction of the syringe and of the needleinside the body. The actuating sleeve 11, on completion of movement,will be locked as described previously. Therefore, even if the userremoves the autoinjector before full distribution of the product, theneedle safety device is operative.

In normal operation, the injection is terminated and as is describedhereinbelow the piston rod 5 will release the rotation of a trigger 19,optionally with some delay if a retarding device is used. From themoment when the trigger 19 has performed predefined rotation, aprojection 191 of the trigger 19 will cooperate with the upper shoulder95 of the control slide 9, and this control slide 9 will be movedaxially downwards in FIG. 44, which will release rotation of the controlring 2, as described previously.

FIGS. 45 and 46 illustrate retraction of the needle with rotation of thering 2 that will bring the projection 44 of the control sleeve oppositean internal groove of the ring 2, which will cause, under the effect ofthe spring, axial return deformation of the control sleeve 4 inside thecontrol ring 2 and therefore retraction of the syringe and of theneedle.

FIGS. 19 to 26 schematically illustrate an advantageous injection lock.The autoinjector comprises injection means, comprising especially thepiston rod 5, the injection spring 8 and the blocking ring 23, theseinjection means being blocked in a loaded position by said injectionlock. The unblocking of said injection lock then causes actuation ofsaid injection means and therefore injection of the fluid productthrough the needle.

As shown in FIG. 19, said injection lock comprises a control sleeve 4arranged in said central body 1, said control sleeve 4 containing saidpiston rod 5 and said injection spring 8, said piston rod 5 comprising aradial recess 50 receiving at least one blockage element 7 mobilebetween a blocking position and an unblocking position. Said at leastone blockage element 7 is preferably substantially spherical in shape.In the variant shown, there are three blockage elements 7 in the form ofballs, but a different number of blockage elements and forms slightlydifferent to these blockage elements are possible. The followingdescription will be made however in reference to three balls, withoutthis being limiting. Said balls 7 are stressed radially towards theexterior by said piston rod 5 and are held in the blocking position by ablockage member, which in this embodiment is formed by a blocking ring23. This blocking ring 23 is moveable axially relative to said pistonrod 5 between a locking position, in which if keeps the blockageelements 1007 in the blocking position, and an unlocking position, inwhich said blockage elements 1007 are released to unblock said injectionlock, allowing said injection spring to move said piston rod 5 towardsits injection position.

FIG. 20 shows the injection lock in the blocking position. The injectionspring 8 cooperates on the one hand with the piston rod 5 and on theother hand with a pellet support 6. This pellet support 6 is formed by aring arranged around said piston rod 5. The piston rod 5 comprises aperipheral recess 50, provided advantageously with an inclined surface51, formed by narrowing of the diameter of said piston rod 5. Thispiston rod 5 is arranged inside the control body 4 and is likely to bemoved axially towards the left in FIG. 20 to push the piston of thesyringe A inside the syringe and distribute the fluid product containedin said syringe through the needle.

As evident in FIG. 20, the balls 7 are arranged in said recess 50 formedin the piston rod 5 and cooperate therefore on the one hand with theinclined wall 51 of the piston rod 5 and on the other hand with theupper surface 61 of said pellet support 6.

The inclined surface 51 of the piston rod is in contact with the balls 7such that under the effect of the compressed spring 8, said inclinedsurface 51 exerts a reaction force F1 on the balls 7, this force F1 notbeing exactly axial but directed slightly towards the exterior,stressing the balls 7 radially towards the exterior of the blockingposition of FIG. 20.

The blocking ring 23 is provided radially outside the balls 7 toradially block said balls in the blocking position. In reference moreparticularly to FIG. 22, it is evident that the balls can be arranged inhousings of the control sleeve 4, the blocking ring 23 comprisingprojections 231, one for each ball 7, which are positioned in contactwith the balls 7 to prevent the latter from being moved radially towardsthe exterior.

The pellet 6 transmits the force F3 of the spring 8 to the balls 7, andthe blocking ring 23 exerts a reaction force F2 on the balls 7 toprevent radial movement thereof. Therefore, it is the balls 7 whichsupport all the forces exerted on the lock in the blocking position,with balance at three points under the effect of forces F1, F2 and F3.Such a lock is particularly stable and robust and especially resistsdrops tests. These tests simulate the fact of dropping the autoinjectorto the floor after the cap 14 has been removed, the aim being to avoidtriggering of the injection lock during this fall. In particular, noforce is exerted on the structural pieces of the autoinjector, such asthe central body 1 or the lower body 10. This lock accordingly avoidsthe risk of untimely disassembly of the device during transport orhandling.

It is evident that the balls 7 could be replaced by non-sphericalelements but of rounded more complex shape, for example in the form of acylinder or bean, to further improve the stability of the lock. In thiscase, these non-spherical mobile elements could be made of metal, forexample by steel wire cutting.

When the needle of the syringe has fully penetrated the body of theuser, and only after this total insertion, as is described below, theblocking ring 23 is moved according to arrow E1 in FIG. 21. The effectof this is to release the balls 7 from their blocking position, thelatter being moved radially towards the exterior according to arrow E2.As a variant, the blocking ring 23 could also be moved in rotationtowards a position where it releases the balls. The pellet support 6then stops against an internal edge of the control sleeve 4, as shown byarrow E3 in FIG. 21. In this position, the piston rod 5 is no longerheld by the balls 7 and it is therefore moved axially, that is, towardsthe left in FIG. 21, to perform injection of the product. The balls 7can no longer return to the blocking position, prevented by the pellet6, as is evident in FIG. 21.

With slightly different views FIGS. 23 to 26 illustrate the twopositions of blocking and unblocking of the injection lock, as describedabove in reference to FIGS. 20 and 21.

The injection lock shown in FIGS. 19 to 26 unlocks a substantial forceexerted by a compressed spring, in this case the injection spring 8, byexerting a relatively weak and easily controlled force on the blockingring 23. In particular, the force necessary to move said blocking ring23 into the unblocking position can represent only 10%, or even only 5%,of the force exerted by the injection spring 8. This represents a verylarge yield which ensures easy and reliable actuation of the device.

When the injection is finished, that is, when the piston rod 5 hasreached its end position in which the piston of the syringe A has beenmoved to inject the fluid product, a trigger 19 is actuated to retractthe syringe and therefore the needle.

During the injection phase, a locking finger 20 extends through thetrigger 19 and into the central channel 151 of the upper body 15. Aretardant spring 18, here a spiral spring, stresses said trigger 19 inrotation. This rotation is blocked by the locking finger 20,advantageously oblong in shape, which is adapted to turn together withsaid trigger 19, but that is blocked in rotation by said central channel151 of the upper body 15. During the injection phase, the piston rod 5moves axially, that is, towards the left in FIG. 28. As it moves, itwill pull on the wire 21 that will therefore extend out of the channel151. As the locking finger 20 is arranged inside the central channel151, rotation of the trigger 19 is blocked. When the piston rod 5approaches the end of the injection path, the wire 21 is completely tautand held between the piston rod 5 and the locking finger 20, and anyextra movement of the piston rod 5 will therefore axially move thelocking finger 20 out of said central channel 151. When the piston rod 5reaches the end position of the end of injection, the locking fingerstops cooperating with the central channel 151, and the trigger 19 andthe locking finger can turn under the effect of the retardant spring 18.As evident in FIG. 31, the trigger 19 comprises an external inclinedramp 190 that can comprise a projection 191 to one side. When thetrigger 19 will have described a predefined rotation, typically aboutone turn, this projection 191 will cooperate with the control slide 9,which will move the latter axially and trigger retraction of the needle,as has been described previously.

FIGS. 27 to 31 illustrate an advantageous retarding device.

The main aim of this retarding device, which is optional in anautoinjector, is to offset retraction of the syringe A in time andtherefore of the needle out of the body of the user after completion ofinjection of the fluid product inside said body. This especially enablesdiffusion for a few seconds of the product after its injection. Such aretarder also produces a benefit for the user who no longer has tocount, for example up to 10, after injection, the time taken for thiscounting varying widely from one user to another. A retarder makes thesequence of use of an autoinjector easy.

The mechanical retarder shown in FIGS. 27 to 31 offsets this retractionby a few seconds, this delay being predeterminable.

FIG. 27 illustrates an exploded schematic view of this retarding device.This comprises the upper body 15, several planetaries 16 with severalsatellites 17, the retardant spring 18, the trigger 19, the lockingfinger 20, the wire 21 and the piston rod 5. It is this piston rod 5that will perform actuation of the retarding device when it arrives atthe end of the injection path with all the product that has beeninjected.

FIG. 28 shows the retarding device before its actuation. It is evidentthat the actuation rod 5 is connected to the locking finger 20 by meansof the wire 21. In this position, the wire 21 and the locking finger 20extend inside a central channel 151 of the upper body 15 and into thetrigger 19. The upper body 15 comprises a gear 155 on its lateralinternal surface, as clearly evident in FIG. 30. This internal gear 155of the upper body 15 cooperates with a plurality of satellites 17 thatare assembled on planetaries 16. In the example shown in FIG. 28, thereare several planetaries stacked axially on each other. The planetaries16 comprise a plate in the form of a disk on which are formed to oneside satellite support rods 161 which each rotatably receive a satellite17. In the example shown, there are three satellites 17 to each stagesuch that there are three rods 161. Each planetary 16 associated withits satellites 17 forms one stage of the retarding device. On the otherside of the plate in the form of a disk the planetary 16 comprises agear 162 adapted to cooperate with the satellites 17 of the adjacentstage. Therefore, as is evident in FIG. 30, the retarding deviceutilizes the principle of epicycloidal trains. Each stage of this devicedemultiplies and/or slows down the rotations of the previous stage.

When a retarding device is used, the trigger 19 cooperates with a firstplanetary 16, whereof the rods 161 extend inside said trigger 19. Thegear 162 of this first planetary 16 cooperates with the satellites of asecond adjacent planetary, which cooperate with the lateral gear 155 ofthe upper body 15, demultiplying the rotation of the first planetary andtherefore of the trigger, and therefore braking this rotation. Eachadditional stage of the epicycloidal train forming the retarder willfurther demultiply these rotations, and therefore further brake therotation of the trigger 19. Therefore, with four stages as shown in thefigures, the rotation of the trigger 19 can be made as a single turn,whereas the last planetary 16 arranged at the very bottom of the upperbody 15 will describe around fifty turns simultaneously.

According to the number of stages and/or according to the number ofsatellites and/or according to the form of the planetaries and/oraccording to the dimensions of the gears in play, the delay between themoment when the retarding device is triggered and the moment when thetrigger 19 will have performed its predefined rotation to triggerretraction of the syringe can be adjusted fairly precisely, as isexplained later. Friction braking can also be provided, for examplebetween the satellites 17 and the internal gear 155 of the upper body15.

The retarding device therefore offsets the moment when said trigger willactuate retraction of the needle by a predetermined time, from themoment when the injection phase is finished.

It is evident that the deployable wire principle connected on the onehand to the piston rod 5 and on the other hand to the locking finger 20can be used without the train epicycloidal system such as shown in FIGS.27 to 31, as will be especially described hereinbelow in reference tothe second embodiment. This wire, of minimal bulk, ensures thatretraction of the needle commences only once the injection phase isfully finished, especially compensating any manufacturing tolerances.More generally, the use of a wire reduces the bulk of the device.Because of this, it can be used advantageously for various functions inan autoinjector, as there is a need to pull one piece relative toanother.

According to an advantageous aspect, the external shell 22 comprisesseveral indicators which inform the user of the advance of sequences forpricking, injection and retraction. In case of use of a retardingdevice, display of said delay can also be provided.

Therefore, as evident in FIGS. 2a to 2f , the external shell 22 cancomprise several display windows, in this case three windows 221, 222,223, which display mobile elements during different phases of actuation,these elements comprising indicators, typically colors.

Therefore, the control slide 9, which at rest is in a first positionrelative to the central body 1, moves axially towards a second positionduring movement of the actuating sleeve 11. It remains in this secondposition throughout the injection phase, and returns in the direction ofits first position during retraction of the needle. It is only when theactuating sleeve returns to its second projected position that thecontrol slide reaches this first position. This control slide 9 cancomprise one or more color indicators, for example a red zone as evidentin FIG. 1. This slider can therefore be used to indicate on the one handthe projected position of the actuating sleeve 11 (first position) andon the other hand the pricking and injection phase (second position).

The trigger 19, which triggers the retraction of the needle oncompletion of injection, can also comprise an indicator, for example ared zone which displays when said trigger has performed its predefinedrotation and actuated retraction of the needle.

Therefore, the first display window 221 can be the window for completionof injection, that is, when a predefined color, red for example, appearsin the window 221, the injection is finished and the syringe has beenretracted. The user therefore knows that when this first display windowis red he can remove the autoinjector from his body in complete safety.This indication can be supplied for example by the trigger 19.

The second display window 222 can be that of the phases of pricking andinjection, which changes to red at the start of the pricking phase atthe end of the injection phase. This prevents the user from removing theautoinjector from his body during these phases, which can last severalseconds. This indication can be supplied by the actuator slider 9.

The third display window 223 can be that of the actuating sleeve 11,with the red displayed when the actuating sleeve 11 is in a projectedposition out of the lower body. This third display window 223 istherefore red prior to actuation, then again after use when theactuating sleeve 11 is locked in the safety position. This indicationcan be supplied by the control slide 9. In the example shown, the redzone of the actuator slider 9 moves from the third display window 223,prior to actuation (FIG. 2a ), to the second display window 222 (FIG. 2c) when the actuating sleeve is in the actuation position where ittriggers the pricking phase. During this transition, said red zone isnot evident as it is located between said windows 223 and 222 (FIG. 2b). During the phases of pricking and injection, the control slide staysin its second position (FIG. 2c & FIG. 2d ). When the control slide 9 isagain moved axially towards its first position by the trigger 19, toactuate retraction of the needle, the red zone changes back from thesecond window 222 to the third window 223, being invisible again (FIG.2e ), to finally reappear in the third window 223 when the actuatingsleeve is locked in the second projected position (FIG. 2f ).

In this configuration, the combination of red in the first and thirddisplay windows 221 and 223 ensures the end of the process of use of theautoinjector, with the needle retracted and the actuating sleeve 11locked, ensuring optimal safety.

Of course, other means of display or indication are also possible andsaid external shell 22 can comprise any number of display windows, ofany form and dimension, and that could be positioned differently to thevariant shown in the figures. The same window can especially displayseveral different functions.

Optionally, in the first display window 221 or in another displaywindow, for example an additional display window, the state of theretarding device can be displayed, for example with a count. This couldbe done for example with numerical values inscribed on the lateralexternal edge of the trigger which moves progressively into anappropriate display window and which in seconds displays the count ofthe retarder. Other variants are of course also possible.

This external shell 22 can also comprise a button or buttons forpricking and/or retraction of the needle if the autoinjector providessuch buttons to perform pricking and/or retraction of the needle.

The external shell 22 could also comprise a temperature indicator of theproduct to be injected. In fact, many products to be injected are storedat 8° and it is often recommended to bring them out 30-60 minutes inadvance. If the product is too cold at the moment of the injection, thiscan cause pain for the patient. For example, the shell 22 could comprisetemperature display of the tank containing the product to be injected.As a variant, a label could also be provided which changes color withtemperature. This temperature indicator could be provided on the shell,or on the tank, especially the syringe, and be visible through a windowof the shell.

FIGS. 47 to 74 c illustrate several variants of a second embodiment ofthe invention. This second embodiment relates to a simplifiedautoinjector, comprising fewer pieces, and therefore simpler and lesscostly to make and assemble.

In the variant of FIG. 47 of this second embodiment, the autoinjectorcomprises a lower body 1010, an actuating sleeve 1011, a spring 1012 ofthe actuating sleeve, a cap 1014, a control sleeve 1004, a piston rod1005, a pellet support 1006, three blockage elements 1007, here in theform of balls, an injection spring 1008, a click member 1500, a wire1021, and an external shell 1022.

The cap 1014 especially locks the autoinjector during transport andstorage. As this cap is installed on the lower body 1010, it preventsany actuation of the actuating sleeve 1011 and therefore any triggeringof the autoinjector.

As for the first embodiment, the syringe A is a pre-filled syringe. Itcomprises advantageously a needle cap B which protects and isolates theneedle prior to use of the autoinjector. Advantageously, this needle capB is removed automatically at the moment when the cap 1014 is removedfrom the lower body 1010.

It is evident that this second embodiment has several elements similarto the first embodiment, these similar elements being designated byreference numerals similar to those of the first embodiment, augmentedby 1000. Therefore, for example, the actuating sleeve reference 11 inthe first embodiment is now reference 1011. Consequently, in thedescription of this second embodiment, it is mainly the differencesrelative to the first embodiment that is described, given that the otherelements and functions remain similar, if not identical, between the twoembodiments.

The principal difference in this second embodiment is that the tank, inthis case the syringe A, is fixed relative to the lower body 1010,relative to the control sleeve 1004 and relative to the external shell1022. Therefore, to perform pricking of the needle only the actuatingsleeve slides relative to the rest of the autoinjector. In this secondembodiment there is therefore no device for syringe movement.

FIGS. 48a to 48e illustrate the sequences of the use of the autoinjectorof FIG. 47.

In FIG. 48a , the autoinjector is in a rest position prior to use, thecap 1014 having been removed.

When the user wants to use the autoinjector, he takes the device, forexample at the level of the external shell 1022 and presses theactuating sleeve 1011, which in a first projected position projects outof the lower body 1010, against the part of the body where he wants toperform the injection. In FIG. 48b , it is evident that the pressureexerted by the user on the actuating sleeve 1011 causes sliding thereoftowards the interior of the lower body 1010, which reveals the needleand therefore its pricking due to the pressure exerted by the user onthe autoinjector.

When the actuating sleeve 1011 reaches its actuation position, which isits end position inside the lower body 1010, it causes triggering of theinjection phase that is shown in FIGS. 48c and 48d . It is noted thatthe piston rod 1005 slides inside the syringe A by pushing the pistonthereof under the effect of the injection spring 1008. The product istherefore distributed.

On completion of the injection, when the user removes the autoinjectorfrom the injection site, the actuating sleeve 1011 is again shifted outof the lower body 1010 towards a second projected position, under theeffect of the spring of the actuating sleeve, with locking of saidactuating sleeve 1011, which ensures absolute safety for the user andavoids any risk of injury with the needle after use of the device. It isevident that the first and second projected positions of the actuatingsleeve, which, in the example shown, are different positions, couldoptionally be identical.

In this second embodiment, as evident especially in FIGS. 49a to 52,said actuating sleeve 1011 also comprises a flexible foot 1110 that isflexible laterally only, that is, it deforms in the direction peripheralof the actuating sleeve 1011 only. An actuating sleeve 1011 providedwith such a flexible foot is even simpler to mold than the flexible footwith double flexibility of the first embodiment, which is favorable fromthe point of view of manufacturing costs. With a foot flexible laterallyonly, there is also a gain in radial bulk, which especially improves theaesthetics of the autoinjector. The flexible foot 1110 advantageouslycomprises a rod part 1111 that is flexible and which terminates in ahead part 1112.

In a first variant, illustrated in FIG. 51, said flexible foot 1110 isadapted to deform laterally relative to said lower body 1010 on the onehand when said actuating sleeve 1011 is moved from its first projectedposition towards its actuation position and on the other hand when saidactuating sleeve 1011 is moved from its return actuation positiontowards its second projected position. In this case, the head 1112 ofthe flexible foot must overcome resistance to deform laterally at thestart of the actuation, to create a sort of precompression which ensuresthat when the actuating sleeve will slide towards the interior of thelower body 1010, the needle will suddenly penetrate the injection siteas far as its planned injection position. In the example of FIG. 51,this resistance is formed by a shoulder 1019 of the lower body 1010.

Preferably however, in a second variant shown in FIGS. 50 a, b, c and52, said flexible foot 1110 is not deformed when said actuating sleeve1011 is moved from its first projected position, prior to actuation,towards its actuation position, and said flexible foot is deformedlaterally only when said actuating sleeve 1011 is moved from itsactuation position towards its second projected position, at the end ofuse. In this variant, prior to actuation, the actuating sleeve 1011 isconnected to said lower body 1010 by at least one scored bridge 1500.This embodiment especially allows easy molding, and therefore reducedmanufacturing costs, adaptation and management of the breaking force ofthe scored bridges facilitated by the dimensioning of these bridges, andan evidence of use function.

FIG. 52 illustrates two scored bridges 1500, adapted to break andtherefore enable sliding of the actuating sleeve 1011 relative to thelower body 1010 when the user presses the autoinjector on the injectionsite using predetermined pressure.

When the actuating sleeve 1011 returns from its second actuationposition towards its projected position, under the effect of the spring1012, when the user removes the autoinjector from the injection site,the operation of the flexible foot 1110 can be identical to thatdescribed within the scope of the first embodiment, with an inclinedgroove, a final reception zone and an axial shoulder cooperating withthe head of the flexible foot to block it in the second projectedposition.

In a variant, the lower body 1010 can comprise a shoulder 1019 thatextends axially towards the interior by a ramp 1018, for example formedby a groove, which is at least partially inclined. Therefore, when theactuating sleeve 1011 returns from its actuation position towards itssecond projected position the head 1112 of the flexible foot 1110 willbe deformed laterally by said ramp 1018, to finally returns to clip inunder the projection 1019 in the second projected position to block theactuating sleeve.

In the variant of FIG. 51, this same projection 1019 can cooperate withthe head 1112 of the flexible foot 1110 at the same time at the start ofactuation to create precompression and at the end of actuation to blockthe actuating sleeve in the second projected position. Of course, twodifferent shoulders can also be provided to carry out these twofunctions.

It is evident that the flexible foot 1110 can be fixed to said actuatingsleeve 1011 only at the level of its rod part 1111, with in this casethe head 1112 forming a free end of said flexible foot. By way ofvariant, the flexible foot could also be fixed to said actuating sleeveon two sides, with the head 1112 arranged between the two fasteningpoints. This execution reinforces especially the robustness of theflexible foot. This variant could also be adapted to the flexible footof the first embodiment.

In the variants of FIGS. 49a to 52, the flexible foot 1110 of theactuating sleeve 1011 cooperates advantageously with an opening 103, aninclined groove 104, a final reception zone 105 and an axial shoulder106 of the body 1010 that are similar to these same elements describedpreviously in reference to FIGS. 4 to 18.

FIGS. 72 to 74 c illustrate another variant embodiment of the actuatingsleeve. In this variant, the reference numerals will be similar to thoseabove, but augmented by 1000. Therefore for example, the actuatingsleeve will be referenced 2011. In this particular variant, thefunctions of the actuating sleeve 2011 and of the body 2010 arereversed, the body 2010 comprising the flexible foot 2110, and theactuating sleeve 2011 comprising the profile that will cooperate withsaid flexible foot 2110. The operation however remains similar to thatdescribed previously, with the flexible foot 2110 that willprogressively slide in said profile, and especially in an inclinedgroove 2104 that connects an opening 2103 to a final reception zone2105. To lock the device at the end of actuation in the final receptionzone 2105, the flexible foot 2110 will clip onto the shoulder 2106, asis evident in FIG. 74c . As described previously, the flexible foot mustadvantageously overcome resistance to deform at the start of theactuation to create a sort of precompression which ensures that when theactuating sleeve 2011 will slide towards the interior of the lower body2010 the needle will suddenly penetrate the injection site as far as itsplanned injection position. In the example of FIGS. 72 to 74C, thisresistance is formed by a shoulder 2019 of the actuating sleeve 2011. Itis evident that the flexible foot 2110 can be formed monobloc on thebody 2010, or as a variant be formed on a separate piece assembled onsaid body 2010, for example for reasons of simplicity and/or molding.

FIGS. 53a, b , 54 a, b, 57 a, b, c and 58 a, b, c illustrate adaptationto the second embodiment of the injection lock described in the firstembodiment.

As described previously, the autoinjector comprises injection means,comprising especially the piston rod 1005 and the injection spring 1008,these injection means being blocked in a loaded position by saidinjection lock. The unblocking of said injection lock causes actuationof said injection means and therefore injection of the fluid productthrough the needle.

As shown in the different FIGS. 53, 54, 57 and 58 said injection lockcomprises a control sleeve 1004 arranged in said external shell 1022,said control sleeve 1004 containing said piston rod 1005, said injectionspring 1008 and a pellet support 1006. In the blocking position shown inthe different FIGS. 53 and 57, the injection spring 1008 cooperates onthe one hand with the piston rod 1005 and on the other hand with saidpellet support 1006. This pellet support 1006 is formed by a ringarranged around said piston rod 1005. Said piston rod 1005 comprises atleast one radial recess 1050 receiving at least one blockage element1007 mobile between a blocking position and an unblocking position.Advantageously, there are three blockage elements 1007, preferablysubstantially spherical in shape, especially in the form of balls, but adifferent number of blockage elements and rounded forms different tothese blockage elements are possible. Said blockage elements 1007 arestressed radially towards the exterior by said piston rod 1005 and areheld in the blocking position by a blockage member, which in this secondembodiment is formed by said control sleeve 1004. This control sleeve1004 is moveable axially relative to said piston rod 1005 between alocking position in which it holds the blockage elements 1007 in theblocking position, and an unlocking position in which said blockageelements 1007 are released to unblock said injection lock, allowing saidinjection spring to move said piston rod 1005 towards its injectionposition.

As evident more particularly in FIGS. 57a and 58a , the control sleeve1004 comprises one or more windows 1400 that allow the blockage elements1007 to move when the control sleeve has been moved towards itsunlocking position, shown especially in FIG. 58. The movement of thecontrol sleeve 1004 from its locking position towards its unlockingposition is performed by a projection 1411 of the actuating sleeve 1011,which will cooperate with a shoulder 1410 of the control sleeve 1004such that the control sleeve 1004 is in the unlocking position when theactuating sleeve 1011 is in the actuation position. Since said pistonrod 1005 is now not blocked by said blockage elements 1007, it is movedout of the control sleeve by said precompressed injection spring 1008 tomove the piston into the tank and inject product through the needle.This type of lock enables unblocking with little effort, ensuring soundand tactile comfort for the user during injection.

Advantageously, the autoinjector comprises a sound and/or tactileindication device 1500 to indicate by an audible or by a tactileindication to the user that the injection phase is finished. This deviceis described hereinbelow in relation to three variants of the secondembodiment, but it could also be adapted to an autoinjector madeaccording to the first embodiment.

According to a first variant embodiment, this sound and/or tactileindication device 1500 comprises a central piece 1501 provided with atleast one lateral piece 1502 connected to said central piece 1501 by apliable and/or scored link 1503. In the example shown in FIGS. 55 to 59c, there are two lateral pieces 1502, each connected to the centralpiece by a scored link.

The central piece 1501 is connected to said piston rod 1005 by said wire1021, which is fixed on the one hand to said central piece 1501 and onthe other hand to said piston rod 1005. In the blocking position of theinjection lock, before the start of the injection, the wire 1021 iswound around the piston rod and the central piece 1501 is arrangedoutside the control sleeve 1004. When the control sleeve 1004 is movedtowards its unlocking position, shown especially in FIG. 58a , an upperedge of said control sleeve 1004 makes contact with said lateral pieces1502. During the injection, when the piston rod 1005 moves relative tothe control sleeve 1004, the wire 1021 will progressively unwind untilit is stretched on completion of injection, as shown in FIG. 58b . Fromthis moment, the wire 1021 will exert traction on the central piece1501, under the effect of the reaction of the upper edge of the controlsleeve 1004 causing movement and/or deformation of the lateral pieces.In the example shown with scored links 1503, the latter break, allowingthe lateral pieces 1502 to move above the central piece 1501, andtherefore the control sleeve 1004 to move axially relative to theexternal shell 1022, as evident especially in FIG. 59a . As thismovement happens under the pressure exerted by the injection spring 1008on the control sleeve 1004, it is relatively brusque and creates a shockbetween the control sleeve 1004, the lateral pieces 1502 and/or theexternal shell 1022. This shock is audible and/or tactile for the userwho therefore receives information on the completion of injection. Afteractuation of this sound and/or tactile indication device, the wire 1021is no longer fully stretched, as illustrated schematically in FIGS. 59aand 59 b.

FIGS. 60 to 64 c illustrate a second variant of the sound and/or tactileindication device. In this second variant, the central piece is omitted.The sound and/or tactile indication device 1500 comprises a mobileelement that is here formed by the control sleeve 1004, which comprisesat its distal end relative to the needle one or more deformable feet1510, which on completion of injection will stop against the externalshell 1022. This control sleeve 1004 is in a first position relative tothe external shell 1022 prior to actuation of the autoinjector, as shownin FIG. 64a . During actuation, the opening of the injection lock, andtherefore the start of the injection phase, causes movement of thecontrol sleeve 1004 towards a second position, evident in FIG. 64B. Herea central piece called a key 1120 advantageously replaces the wire ofthe preceding first variant. This key 1120, especially evident in FIGS.63a and 63b , comprises a rod part 1121 that extends inside the pistonrod 1005, this rod part being similar to the wire of the first variant.The key 1120 also comprises a head part 1122, arranged at the upper end(or distal end relative to the needle) of said key. This head partcooperates with said deformable feet 1510 of the control sleeve 1004 toprevent it from deforming radially towards the interior. Because ofthis, these deformable feet 1510 block said control sleeve in its secondposition relative to said external shell 1022. The lower end (orproximal end relative to the needle) of the rod part 1121 cooperateswith the piston rod 1005 on completion of injection, causing sliding ofsaid key 1120 relative to the control sleeve 1004 and to the externalshell 1022. Therefore, after this sliding, the head part 1122 no longercooperates with the feet 1510 of the control sleeve, which can deformradially towards the interior. The effect of this is to unblock thecontrol sleeve 1004 that is then shifted towards a third positionagainst said external shell 1022 under the effect of the force exertedby the injection spring 1008. This creates an audible shock or otherwisedetectable by the user who now knows that the injection is finished.

Advantageously, the external shell 1022 comprises one or more,especially three, display windows 1023 in which said deformable feet1510 become visible at the same time as they tap against the externalshell. This allows visual indication simultaneously to the sound and/ortactile indication.

Advantageously, said at least one display window 1023 is formed on or inthe distal end edge of said external shell 1022, being visible at thesame time in the axial direction and in the radial direction of saidshell. This execution avoids masking the display window or the windows1023 when the autoinjector is handled by the user, ensuring properdisplay of information displayed in said at least one display window1023 throughout the phase of use, from start to finish. With severaldisplay windows 1023, especially three, distributed around the distalend edge of the body 1022, this ensures perfect display irrespective ofthe orientation of the autoinjector at the moment of its use.

The variant embodiments of the second embodiment of the autoinjectordescribed above therefore define a control sleeve 1004 having threedifferent positions: prior to injection when it is in the lockingposition, during injection when it is in the unlocking position, andafter injection when it has actuated the sound and/or tactile indicationdevice. This easily displays these three distinct positions in asuitable display window 1221. Of course, the external shell 1022 of thissecond embodiment could also comprise several display windows, asdescribed in the first embodiment.

FIGS. 65 to 71 illustrate a third variant embodiment of the sound and/ortactile indication device. In this variant, which is similar to thesecond variant above, the mobile element of the sound and/or tactileindication device is not formed by the control sleeve 1004 but by thesupport pellet 1006 on which the injection spring 1008 is supported.FIGS. 66a and 66b shows this support pellet, which comprises one or moredeformable feet 1520, which are similar to the deformable feet 1510 ofthe control sleeve 1004 of the second variant above. The operation isalso similar, with the key 1120 which blocks by its head 1122 the radialdeformation of said feet 1520, which blocks the pellet support relativeto the external shell. When the piston rod has the key 1120 slide oncompletion of injection, by traction on the rod part 1121, the head part1122 of the key 1120 will release said feet 1520, which deform radiallytowards the interior and will allow said pellet support 1006 to beprojected against said external shell, creating a sound and/or tactileindication. Advantageously, as described previously, a visual indicationis also supplied by a display window or windows 1023 of the externalshell that show the deformable feet 1520 of the pellet support 1006.

FIGS. 69 to 71 illustrate in more detail the operation of the soundand/or tactile indication device. In FIG. 69, the deformable foot 1520is prevented from deforming radially towards the interior by thepresence of the head part 1122 of the key 1120. In FIG. 70, the key hasbeen moved by the piston rod and consequently the deformable foot 1520has deformed radially towards the interior. This has caused movement ofthe support pellet 1006 in the external shell, with a shoulder 1521 ofthe deformable foot which stops on a part of said external shell,generating the sound and/or tactile indication, for example an audibleor sensitive vibration. Simultaneously, the end of the deformable foot1520 has been positioned in the window 1023 of the external shell 1022,as is evident in FIG. 70. FIG. 71 illustrates the end of the injection,with the piston rod 1005 that will pull on the rod part 1121 of the key1120 to move the latter.

The present invention applies to devices used especially for treatmentof auto-immune diseases, for example of rheumatoid arthritis, multiplesclerosis, Crohn's disease type, for treatments against cancer, forantiviral treatment, for example of hepatitis type, for treatmentagainst diabetes, for treatments against anemia or for treatment ofstress, for example in the event of anaphylactic shock.

Even though the present invention has been described in reference toseveral advantageous modes and variant embodiments, which combineseveral functional modules, it is understood that the different modulesdescribed can be used independently of each other. In particular, theactuating sleeve and/or the device for movement of syringe for prickingand/or retraction and/or the injection lock and/or the retarding deviceand/or the sound and/or tactile indication device could be usedindependently of each other. Pricking of the needle and/or retraction ofthe needle after injection could be controlled by one or more button(s).The sound and/or tactile indication device of the second embodimentcould be used with an autoinjector of the type described in the firstembodiment. Other modifications are also possible for the expert withoutdeparting from the scope of the present invention such as defined by theattached claims.

The invention claimed is:
 1. An autoinjector comprising a lower bodyreceiving a tank, said tank containing fluid product and comprising apiston and a needle, said autoinjector comprising a central bodyfastened to said lower body and an actuating sleeve provided with acontact end designed to make contact with the body of the user, saidactuating sleeve being moveable between a projected position and anactuation position, said actuating sleeve being in a projected positionprior to and after actuation of the autoinjector, an injection mechanismcomprising the piston rod and an injection spring being provided toinject said fluid product through said needle when said needle is in aninjection position in which it is inserted in the body of the user, saidautoinjector comprising a tank movement device comprising a controlring, a control sleeve and a control slide, on the one hand to move theneedle towards said injection position, and on the other hand to retractsaid needle out of the body of the user after injection of the fluidproduct, wherein the control ring is rotatably mounted in said centralbody, said control ring comprising a first internal inclined profileadapted to cooperate with a projection of the control sleeve secured tothe tank, said control sleeve being moveable axially in said centralbody, such that rotation of the control ring causes said control sleeveto move axially, wherein said control ring is stressed in rotation by apricking spring, formed by a torsion spring, the rotation of saidcontrol ring being blocked by the control slide that is moveable axiallyin said central body, said actuating sleeve cooperating, when it arrivesin its actuation position, with said control slide to move it axially soas to unblock the rotation of said control ring and thus move the tanktowards the injection position of the needle, the control slidecomprising a projection that blocks the rotation of the control ringuntil the actuating sleeve is in its actuation position, said projectioncooperating with an external inclined ramp of said control ring duringits rotation, which brings the needle into its injection position, suchthat said control slide is moved axially relative to said control ringduring said rotation; and wherein the injection mechanism cooperate withthe tank movement device after injection of the fluid product to retractthe needle.
 2. The autoinjector according to claim 1, in which saidactuating sleeve cooperates, in the actuation position, with said tankmovement device to move said needle towards its injection position. 3.The autoinjector according to claim 1, comprising an injection lock toblock said injection mechanism, said tank movement device unblockingsaid injection lock and actuating said injection mechanism when theneedle is in the injection position.
 4. The autoinjector according toclaim 1, in which, after the needle has arrived in the injectionposition, the control ring unblocks the injection lock, actuating theinjection mechanism, said control slide cooperating with said controlring to block the rotation of said control ring once again.
 5. Theautoinjector according to claim 4, in which a trigger cooperates withsaid control slide after the end of injection to move it axially toblock the rotation of said control ring once again, and thus move thetank towards the retracted position of the needle.
 6. The autoinjectoraccording to claim 1, in which said actuating sleeve cooperates withsaid control slide such that when said actuating sleeve is returned toits second projected position after or during actuation, said controlslide is moved into position for unblocking the rotation of the controlring, so as to actuate retraction of the needle.
 7. The autoinjectoraccording to claim 1, wherein the piston and the needle are part of apre-filled syringe.
 8. An autoinjector comprising a lower body receivinga tank, said tank containing fluid product and comprising a piston and aneedle, said autoinjector comprising a central body fastened to saidlower body and an actuating sleeve provided with a contact end designedto make contact with the body of the user, said actuating sleeve beingmoveable between a projected position and an actuation position, saidactuating sleeve being in a projected position prior to and afteractuation of the autoinjector, an injection mechanism comprising thepiston rod and an injection spring being provided to inject said fluidproduct through said needle when said needle is in an injection positionin which it is inserted in the body of the user, said autoinjectorcomprising a tank movement device comprising a control ring, a controlsleeve and a control slide, on the one hand to move the needle towardssaid injection position, and on the other hand to retract said needleout of the body of the user after injection of the fluid product,wherein the control ring is rotatably mounted in said central body, saidcontrol ring comprising a first internal inclined profile adapted tocooperate with a projection of the control sleeve secured to the tank,said control sleeve being moveable axially in said central body, suchthat rotation of the control ring causes said control sleeve to moveaxially, wherein said control ring is stressed in rotation by a prickingspring, the rotation of said control ring being blocked by the controlslide that is moveable axially in said central body, said actuatingsleeve cooperating, when it arrives in its actuation position, with saidcontrol slide to move it axially so as to unblock the rotation of saidcontrol ring and thus move the tank towards the injection position ofthe needle, the control slide comprising a projection that blocks therotation of the control ring until the actuating sleeve is in itsactuation position, said projection cooperating with an externalinclined ramp of said control ring during its rotation, which brings theneedle into its injection position, such that said control slide ismoved axially relative to said control ring during said rotation; andwherein the injection mechanism cooperates with the tank movement deviceafter injection of the fluid product to retract the needle.
 9. Theautoinjector according to claim 8, wherein the pricking spring is formedby a torsion spring.
 10. The autoinjector according to claim 8, whereinthe injection mechanism cooperates with the tank movement device afterinjection of the fluid product to retract the needle so that a distalfree end of the needle is within the lower body and wherein the contactend of the actuating sleeve in the projected position extends beyond adistal end of the lower body.
 11. The autoinjector according to claim 8,wherein the piston and the needle are part of a pre-filled syringe.